Fenofibrate in Patients with Primary Biliary Cholangitis (PBC)

Inclusion Criteria:

• Must have given written informed consent (signed and dated)

• Participated in the PBC study with fenofibrate (NCT02823353)

• Females of reproductive potential must use at least one barrier contraceptive and asecond effective birth control method during the study and for at least 90 daysafter the last dose. Male subjects who are sexually active with female partners ofreproductive potential must use barrier contraception and their female partners mustuse a second effective birth control method during the study and for at least 90days after the last dose

Exclusion Criteria:

• Treatment-related adverse event (AE) leading to fenofibrate discontinuation

• A medical condition, other than PBC, that in the investigator's opinion wouldpreclude full participation in the study or confound its results (e.g., cancer)

• Known history of other liver diseases

• For females, pregnancy or breast-feeding

• Long-term use of immunosuppressive agents

• Any other condition(s) that would compromise the safety of the subject or compromisethe quality of the clinical study, as judged by the Investigator